BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY

    MDR report key: 17795190 · Received September 21, 2023

    Report

    Report Number
    3005099803-2023-05054
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 30, 2023
    Report Date
    October 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729786993
    PMA / PMN Number
    K101786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A23 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO CURL. THIS EVENT WAS REPORTED BY THE SALES REPRESENTATIVE. THE HEALTH CARE FACILITY IS: (B)(6) HOSPITAL PTE LTD (B)(6) BLOCK H11: BLOCK H6 DEVICE CODE HAS BEEN CORRECTED TO CAPTURE THE UPDATED AS REPORTED CODE OF DEVICE SHELF LIFE EXCEEDED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A23 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO CURL. THIS EVENT WAS REPORTED BY THE SALES REPRESENTATIVE. THE HEALTH CARE FACILITY IS: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR STONE REMOVAL PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE STENT PIGTAIL WAS NOT CURLED ENOUGH AND IT MAY SLIP OUT FROM THE COMMON BILE DUCT. THE ADVANIX BILIARY STENT WAS REMOVED, AND A NON-BOSTON SCIENTIFIC DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR STONE REMOVAL PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE STENT PIGTAIL WAS NOT CURLED ENOUGH AND IT MAY SLIP OUT FROM THE COMMON BILE DUCT. THE ADVANIX BILIARY STENT WAS REMOVED, AND A NON-BOSTON SCIENTIFIC DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501268 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00532210 0027145417 08714729786993

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown